Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Completed · Phase 3

Conditions studied: Cutaneous T-Cell Lymphoma

In brief

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Key facts

Study ID

NCT01728805

Run by

Kyowa Kirin, Inc.

People needed

372

Starts

2012-11-01

Expected to finish

2021-02-17

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects ≥ 18 years of age at the time of enrollment, except in Japan where subjects must be ≥ 20 years of age at the time of enrollment
• Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
• Stage IB, II-A, II-B, III and IV
• Subjects who had failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
• Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
• Adequate hematological, renal and hepatic function
• Subjects previously treated with anti-CD4 antibody or alemtuzumab were eligible provided their CD4+ cell counts were ≥ 200/mm3
• Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization were eligible provided they continued to receive stable doses of prophylactic antibiotics
• Women of childbearing potential (WOCBP) must have had a negative pregnancy test within 7 days of receiving study medication
• WOCBP and male subjects as well as their female partners of childbearing potential must have agreed to use effective contraception throughout the study and for 3 months after the last dose of KW-0761

You may not qualify if…

• Prior treatment with KW-0761 or vorinostat.
• Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
• Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of <0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years could enroll as long as there was no current evidence of disease.
• Clinical evidence of central nervous system (CNS) metastasis.
• Psychiatric illness, disability or social situation that would have compromised the subject's safety or ability to provide consent, or limited compliance with study requirements.
• Significant uncontrolled intercurrent illness
• Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
• Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and had no active signs of active infection, and whose last active infection was more than 6 months ago, could enter the study, and should have continued to take the prescribed medication for the duration of the study.
• Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
• Known active autoimmune disease were excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
• Was pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.
• History of allogeneic transplant.

Where it is running

• Banner MD Anderson — Gilbert, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Stanford Medical Center — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• The Winship Cancer Institute (Emory University) — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center, Department of Medicine, Section of Hem/Onc — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Universal Dermatology, PLLC — Fairport, New York, United States
• Columbia Presbyterian — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester School of Medicine — Rochester, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Alabama - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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